How Risk Averse Have We Become?

March 26, 2009

Something I've written about before is the swing of the pendulum from the 1990s to the 2000s in terms of public priorities for the FDA. What is the balancing act between risk and benefit when it comes to both food and drugs?

In the 1990s there were two unrelated issues that were prominently influencing our outlook in both food and drugs.

On the food side, globalization in trade was bringing an unprecedented amount of delicious and even exotic foods to the tables of Americans – and bringing it year round. People liked it. People wanted more of it. You could get berries grown in Chile to your table within almost no time. In the middle of winter, you could have a table full of the best that summer has to offer, and in a wider range, with fruits and vegetables people had never seen before.

Lately, however, it has come to our attention that other countries may not have very thorough means of inspection or very ethical producers and fish and dog food and other foods were found to be contaminated with harmful elements. Suddenly globalization didn't seem so hot.

On the drug side, there was a burgeoning HIV/AIDS epidemic. There were no treatments for it, there were only treatments for the vast array of opportunistic infections that people with AIDS suffered. There was a great deal of desire for a cure or at least a treatment that aimed at the underlying cause of AIDS, which was HIV. But the average length of time for a drug's approval was 18 months. That wasn't good enough. Congress set into motion mechanisms that allowed fast track approvals for life threatening drugs and put into place the user fee system that underwrote much faster consideration of drugs for approval, bringing the approval time in most cases down to 10 months. By 1997, with new anti-HIV drugs entering the market, mortality dropped nearly 50% in one year.

Then in 2002, there were some problems with some of the drugs that were being approved, most notably the issues connected with the COX-2 inhibitors, but there were others. And, globalization figures in here too, when the recent contamination in the drug heparin surfaced and was traced back to elements made in China, we realized that many of the components that go into the production of our drugs were not made in the U.S.A. Suddenly, the whole system got questioned.

There is no question, that the last eight years have seen a minimization of efficiency and priorities at the FDA. The FDA can and needs to do a better job. But how risk averse have we become. Is it realistic to expect the FDA to be able to inspect every foreign facility for food production and trace the foreign web of drug production? And do we really want to sacrifice a system that has saved many more lives than it has harmed by doing, as some have advocated, something to the system for quicker approval of drugs? Apply a risk/benefit ratio to that idea and you can quickly see that it is not worth it.

As the pendulum has moved from our desire for access to a desire for safety, we have to ask ourselves how risk averse are we – and are we really willing to risk what progress has been made in favor of asking for risk mechanisms to be put into place that are neither realistic, or in many cases, desirable?

2 Responses to How Risk Averse Have We Become?

Excellent post. The most important point made is that speeding up approvals of new treatments saved many more lives than it harmed. This is an obvious fact, but the media has ignored it in favor of a focus on scandals. In response, the FDA has slowed approvals to a trickle, and has delayed or denied approval (since about 2003) for most new safe and effective drugs for serious and life-threatening conditions. For example, almost nothing new is making it past FDA for the treatment of terminal cancers anymore. The cost in shortened and lost human lives is staggering, far outweighing the rough estimates of people who may have been harmed by a very small number of unsafe drugs, some of which, when viewed objectively, weren’t all that “unsafe.” As Mark argues, the major swing toward risk aversion hasn’t been worth it. Ask any person with a terminal disease if they want the FDA to protect them from progress that might extend their life even if their is a small risk of serious harm, and you will learn something you should have thought of yourself. Their disease poses a much greater risk to them than trying a new drug. They have the more rationale view of risk/benefit, and we should all be listening to them when they tell us, from the perspective of people who really need the FDA to be responsive, to speed up.

So Congress and Obama are going to hold FDA’s feet to the fire on safety, yet at the same time they plan to open the floodgates for drug import from other countries? Do people really think that other countries are going to do a better job than the FDA (even now) in protecting drug safety? When was the last time anyone in the industry has heard of, say, a French drug safety inspector shutting down a plant to address safety violations?
Drugs are only as safe as the weakest link in the chain. Drug importation will make our drug supply less safe. Not that Congress will admit that, even when the inevitable disaster happens (e.g., Chinese counterfeits slipping into “Canadian” Internet pharmacies).

About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.